MAUDE Adverse Event Report: ORTHOFIX, LLC BIOSTIM; BONE GROWTH STIMULATOR CERVICAL STIM

Model Number	655505-0001
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Blister (4537)
Date of Event	08/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not returned for investigation but has been requested to be returned.A review of the dhr was performed - all (b)(4) units from the work order passed final inspection.Should the device return for investigation, failure analysis will be performed at that time.
Event or Problem Description
The patient reported feeling itching and having two blisters on the back of the neck.Patient treats for four hours a day.No additional information had been provided.
Event or Problem Description
The patient reported feeling itching and having two blisters on the back of the neck.Patient treats for four hours a day.No additional information had been provided.
Additional Manufacturer Narrative
The power supply was not returned.As received the device was able to power on and charge and pass post.Device completed 4 hours of treatment of heating test.No damage noted to the system.System operates as designed.A review of the dhr was performed - all (b)(4) units from the work order passed final inspection.Orthofix coninues to monitor reported incident under trend analysis.

• Brand Name: BIOSTIM
• Common Device Name: BONE GROWTH STIMULATOR CERVICAL STIM
• Manufacturer (Section D): ORTHOFIX, LLC; 3451 plano pkwy; lewisville TX 75056
• Manufacturer (Section G): ORTHOFIX, LLC; 3451 plano pkwy; lewisville TX 75056
• Manufacturer Contact: yobana sanchez ; 3451 plano pkwy; lewisville, TX 75056
• MDR Report Key: 22913337
• Report Number: 2183449-2025-00024
• Device Sequence Number: 13066752
• Product Code: LOF
• UDI-Device Identifier: 18257200105632
• UDI-Public: 18257200105632
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P850007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 655505-0001
• Device Catalogue Number: 5505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2025
• Supplement Date Received by Manufacturer: 08/04/2025
• Initial Report FDA Received Date: 08/28/2025
• Supplement Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 74 YR
• Patient Sex: Female